Important Changes in the EU Product Liability Directive: What Does This Mean for Medical Devices? 

Published in: Medical Devices
Published on: 30 January 2025

The European Union has recently adopted Directive (EU) 2024/2853, also known as the new Product Liability Directive. This directive is designed to modernize and expand the EU’s product liability framework. This article discusses the key changes and their impact on the medical devices market. 

person writing medical information

Implementation Timeline 

The new directive came into force on December 8, 2024. Member States have until December 9, 2026, to transpose this directive into national law. The directive applies to products placed on the market after December 9, 2026. This gives companies some time to adjust to the new rules. 

Expanded Scope 

One of the most notable changes is the expansion of the definition of “product.” The new definition now includes software, artificial intelligence (AI), digital services, and digital manufacturing files. Additionally, products provided in exchange for personal data, if supplied in a commercial activity, are now covered by the directive. This means that the scope of product liability has been significantly broadened. 

Liability Changes 

The directive extends liability to integrated or interconnected digital services critical to a product’s functionality. It also introduces new liable parties, such as online platforms, fulfillment service providers, and authorized representatives. Providers of related digital services and operators who substantially modify a product are also covered under the liability. 

Consumer Protection 

Consumers are better protected under the new directive. Compensable harm has been expanded to include psychological damages and data destruction. Rebuttable presumptions are introduced to reduce the information asymmetry between consumers and economic operators. This makes it easier for consumers to assert their rights. 

Evidence and Burden of Proof 

The new directive establishes mechanisms for evidence disclosure for plaintiffs in complex cases. It also introduces presumptions of defect or causal link in certain situations. This helps consumers to strengthen their case in legal disputes. 

Limitation Periods 

The directive maintains a three-year limitation period from the discovery of damage. Additionally, a ten-year expiry period from the product placement on the market is established. For personal injuries with latent effects, the expiry period is extended to 25 years. 

Cybersecurity 

Products are considered defective if they do not meet safety-relevant cybersecurity requirements. This emphasizes the importance of cybersecurity in modern product liability. 

Harmonization 

One of the goals of the new directive is to ensure maximum harmonization between Member States, preventing divergent national provisions. This ensures a more consistent application of the rules within the EU. 

Why is this Important for Medical Devices? 

The changes in the directive significantly increase the responsibilities and potential liabilities for economic operators involved in the production, distribution, and supply of products within the EU market. It is crucial to inform our software customers about this directive so that they can take necessary precautions. This can be done by discussing the new rules with their insurance company and adding the directive to their list of applicable standards and regulations. 

For more detailed guidance and to ensure your compliance, get in touch with our experts 

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